Early Versus Delayed Surgery for Infantile Esotropia

The Hospital for Sick Children

Status: Completed

Conditions: Esotropia

Treatments: Procedure: Stereoacuity Testing; Procedure: Optokinetic nystagmus testing; Procedure: Motion detection testing; Procedure: mVEP Testing; Procedure: Motion discrimination testing

Study type: Observational

Funder types: Other

Identifiers

NCT01166503

1000005134

Details and patient eligibility

About

The goal of this study is to determine whether corrective surgery done earlier than the current standard can better improve the visual and eye movement deficits in children with infantile esotropia (crossed eyes in infancy).

Full description

While there is a uniform agreement among pediatric ophthalmologists that most infantile esotropia requires surgical correction, the proper timing of surgery is controversial. In North America, the typical age at surgery ranges from 11-18 months. Unfortunately, despite successful surgical realignment of the eyes, the sensory and eye movement deficits often persist. Recently, some pediatric ophthalmologists have advocated earlier surgery. The rationale for early surgery stems from animal and human research showing that early realignment of the eyes within an early critical period allows normal development of the sensory and eye movement systems.

Enrollment: 71 patients

Sex: All

Ages: 3 to 23 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. onset of esotropia after 10 weeks of age;
2. constant esotropia ≥ 20° (40 prism diopter or PD) at near (1/3 m) on two examinations, separated by 2-4 weeks; and
3. refractive error ≤ +3.00 diopters (far-sightedness).

Exclusion criteria

1. gestational age < 34 weeks;
2. birth weight ≤ 1500 g;
3. ventilator treatment in the newborn period;
4. history of meningitis or other major medical event;
5. developmental delay;
6. incomitant or paralytic strabismus;
7. manifest nystagmus or head bobbing;
8. prior eye muscle surgery;
9. prior treatment of amblyopia or spectacle correction for refractive errors;
10. presence of structural ocular anomalies.

Trial design

71 participants in 2 patient groups

Early Surgery

Description:

This group will be made up of subjects whose parents choose to have them undergo corrective surgery at or before age 11 months.

Treatment:

Procedure: Stereoacuity Testing

Procedure: Optokinetic nystagmus testing

Procedure: Motion detection testing

Procedure: Motion discrimination testing

Procedure: mVEP Testing

Standard Surgery

Description:

This group will be made up of subjects who present after age 11 months or whose parents choose to have them undergo corrective surgery between 11-18 months.

Treatment:

Procedure: Stereoacuity Testing

Procedure: Optokinetic nystagmus testing

Procedure: Motion detection testing

Procedure: Motion discrimination testing

Procedure: mVEP Testing